Status:
TERMINATED
Long-term Study to Evaluate the Safety of Dutogliptin/PHX1149T in Subjects With Type 2 Diabetes Mellitus
Lead Sponsor:
Phenomix
Collaborating Sponsors:
Forest Laboratories
Conditions:
Type 2 Diabetes Mellitus
Type 2 Diabetes
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to demonstrate that dutogliptin/PHX1149T is safe and tolerable.
Detailed Description
In this study, open-label dutogliptin/PHX1149T will be offered to subjects who complete a Phase 3 core protocol and wish to continue treatment with dutogliptin. This will allow for the collection of l...
Eligibility Criteria
Inclusion
- Completion of all required visits of a qualifying Phase 3 core protocol (e.g., Visit 8/Day 196 of PHX1149-PROT301)
- Current treatment of Type 2 diabetes mellitus as in PHX1149-PROT301
Exclusion
- Except for Type 2 diabetes, any other uncontrolled, serious pulmonary, cardiovascular, hematologic, renal, gastrointestinal, endocrine, neurological, proliferative, immunosuppressive, psychiatric, or urogenital disorder; or diseases of skin and its appendages, the eyes, ears, nose, or throat
- Any condition, disease, disorder or clinically relevant laboratory abnormality which, in the opinion of the investigator, would jeopardize the patient's appropriate participation in this study or obscure the effects of treatment
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2011
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT00865592
Start Date
March 1 2009
End Date
March 1 2011
Last Update
August 11 2010
Active Locations (68)
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Norwalk, California, United States
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Orange, California, United States
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Santa Ana, California, United States
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Daytona Beach, Florida, United States